Associate Director of Engineering
Core
Lead engineering and maintenance functions for GMP/GTP cell therapy manufacturing, ensuring equipment, processes, and systems are reliable, compliant, and scalable.
Role type
Associate Director of Engineering (Manufacturing Operations)
Builds
Cell therapy products for patients with blood, immune, and orthopedic diseases
Domain
Biotechnology / Regulated Manufacturing
Deliverable
infrastructure
Required skills
Equipment lifecycle management, capital project execution, preventive maintenance strategy, root cause analysis, regulatory compliance (CGMP/CGTP), team leadership, data-driven reliability improvement
Preferred skills
CMMS implementation, automation and digital engineering solutions, business intelligence and analytics, Lean or Six Sigma certification, regulatory inspector interaction
Technologies
CMMS, Tableau, Power BI, SQL
Responsibilities
Lead and mentor a high-performing engineering team; own equipment lifecycle management from design to retirement; oversee capital projects from concept to execution; establish and improve preventive maintenance and reliability programs; partner with Manufacturing and QA to support process improvements; lead root cause investigations for equipment and facility systems; develop long-term facility and infrastructure strategy.
Seniority
Senior, hands-on IC with people management